Clinical Trials in Mexico / NCT03838445
Active, not recruiting
Not applicable
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
NCT03838445 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Pulmonary Arterial Hypertension
Investigational drug(s) / intervention(s)
V-Wave Interatrial Shunt
V-Wave Interatrial Shunt: The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovals and straddles the interatrial septum.
Study summary
The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.
Eligibility
Main Inclusion Criteria:
1. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
2. WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines.
3. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.
Main Exclusion Criteria:
1. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude.
2. Mean Right Atrial Pressure \>20 mmHg.
3. Severe restrictive or obstructive lung disease.
4. Evidence of organ dysfunction other than right heart failure.
5. Left ventricular ejection fraction \<40 %.
6. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
7. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.
8. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.
Primary outcome measure(s)
- Safety-Percentage of Treatment patients experiencing major device-related adverse events — 3 months
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation - Safety-Percentage of Treatment patients experiencing any major adverse event — 3 months
Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation - Procedure Success-Percentage of patients successfully implanted with study device — 3 months
Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations - Device Success-Percentage of patients implanted with right to left interatrial flow — 3 months
Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Keck Medical Center of USC | Los Angeles | California | |
| University of California, San Francisco | San Francisco | California | |
| Instituto Nacional de Cardiologia | Mexico City | Mexico |
Other trials for the same condition
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Enrolling by invitation
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03838445 on ClinicalTrials.gov ↗ ← All trials in Mexico